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Persistence of virological benefits following directly administered antiretroviral therapy among drug users: results from a randomized controlled trial.

ABSTRACT: BACKGROUND:Although directly administered antiretroviral therapy (DAART) has demonstrated impressive biological benefits compared with self-administered therapy (SAT) among drug users, the persistence of DAART after transition to SAT has not been examined. METHODS:We conducted a community-based, prospective, randomized controlled trial of 6 months of DAART compared with SAT. The primary outcome was the proportion of subjects who achieved virological success at 6 months postintervention, defined as either a 1.0 log10 reduction from baseline or HIV-1 RNA <400 copies per milliliter. Secondary outcomes included the change from baseline in HIV-1 RNA and CD4 lymphocyte count. RESULTS:Of the 53 subjects in the SAT arm and 88 subjects in the DAART arm, 52 and 82, respectively, provided blood samples at 6 months postintervention. The DAART (n = 88) and SAT (n = 53) arms did not differ on virological success (DAART 58.0% vs. SAT 56.6%, P = 0.64), mean reduction in log10 HIV-1 RNA (-0.79 vs. -0.31 log10 copies/mL, P = 0.53), or mean change in CD4 lymphocyte count (+60.2 vs. -15.4 cells/mL, P = 0.12). In the multivariate analysis, only high levels of social support significantly predicted virological success. CONCLUSIONS:This analysis, from the first randomized controlled trial of DAART among active drug users, failed to show the persistence of the DAART intervention at improving virological outcomes. Additional strategies are needed to ensure the on-treatment benefits persist following the cessation of DAART.

SUBMITTER: Maru DS

PROVIDER: S-EPMC2670996 | biostudies-literature | 2009 Feb

REPOSITORIES: biostudies-literature

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Persistence of virological benefits following directly administered antiretroviral therapy among drug users: results from a randomized controlled trial.

Maru Duncan Smith-Rohrberg DS Bruce Robert Douglas RD Walton Mary M Springer Sandra A SA Altice Frederick L FL

Journal of acquired immune deficiency syndromes (1999) 20090201 2

<h4>Background</h4>Although directly administered antiretroviral therapy (DAART) has demonstrated impressive biological benefits compared with self-administered therapy (SAT) among drug users, the persistence of DAART after transition to SAT has not been examined.<h4>Methods</h4>We conducted a community-based, prospective, randomized controlled trial of 6 months of DAART compared with SAT. The primary outcome was the proportion of subjects who achieved virological success at 6 months postinterve ...[more]

PMID: 19131891

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Project description:BackgroundDepression is highly prevalent among HIV-infected injection drug users (IDUs) and has been associated with poor adherence to antiretroviral therapy and increased morbidity and mortality. Factors associated with changes in depressive symptoms among this group receiving antiretroviral treatment that have not been extensively evaluated.MethodsThis post-hoc analysis of prospective clinical trial analyzes the factors associated with changes in depressive symptomatology using the Center for Epidemiologic Studies of Depression Scale (CES-D) among HIV-infected IDUs enrolled in a prospective, six months randomized controlled trial of directly administered antiretroviral therapy (DAART) versus self-administered therapy.ResultsOf the 127 evaluable IDUs enrolled in the study, 89 subjects (70%) had complete six-month follow-up data. Of these, 58 (63%) met baseline criteria for severe or major depressive disorder (MDD) using the CES-D. CES-D scores improved significantly from baseline to six months overall for the 89 subjects (p=0.01) and for the 58 who had MDD with six-month data (p=0.001). Using multiple regression, an improvement in CES-D score was independently associated with: (1) increase in CD4 count; (2) increase in adherence; (3) non-Caucasian race; and (4) older age. Worsening in CES-D score was associated with: (1) increase in HIV-1 RNA levels; (2) homelessness; (3) poor self-efficacy; (4) active drug use; and (5) male gender. Factors not correlated with changes in CES-D were receipt of DAART, engagement in drug treatment, use of antidepressant medication, and employment. Using generalized estimating equation modeling, factors that remained positively associated with improvements in CES-D score were absence of drug use at six months, having housing, higher self-efficacy, increase in CD4 count and increases in adherence.ConclusionImprovements in depressive symptoms could occur with improvement of alterable factors that are associated with strengthening adherence such as linkages to case management, mental health and substance abuse treatment services as well as through enhancement of social stabilization factors through social support and supportive housing.

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Persistence of virological benefits following directly administered antiretroviral therapy among drug users: results from a randomized controlled trial.

Publications

Persistence of virological benefits following directly administered antiretroviral therapy among drug users: results from a randomized controlled trial.

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